Kornimate/medical-research-clean huggingface dataset:
superiority of artimist versus quinine in children with severe malaria

Conditions: Plasmodium Falciparum Malaria

Summary: the purpose of this study is to demonstrate that artimist (sublingual artemether spray) is better than intravenous quinine in reducing parasite counts by \>= 90% within 24 hours after the start of treatment in children with severe malaria, or uncomplicated malaria with gastrointestinal complications

malaria causes significant morbidity and mortality in children in developing countries, despite the availability of highly effective antimalarial therapy. one of the key contributing factors is the delay in the initiation of treatment. artimist is a sublingual formulation of the established antimalarial treatment, artemether. in previous studies good bioavailability has been demonstrated. in an exploratory study (art003) artimist demonstrated a non statistically significant improvement of 26% (when compared to intravenous quinine) in the numbers of patients experiencing a parasite reduction of \>= 90% within 24 hours of the initiation of treatment. this phase 3 study is being conducted to establish whether treatment with artimist in children with severe falciparum malaria or uncomplicated falciparum malaria with gastrointestinal complications is at least 20% superior in providing parasitological success (defined as \>= 90% reduction in parasite count at 24 hours after start of treatment) when compared to intravenous quinine.

Eligibility criteria:
inclusion criteria: 1. the patient's legally acceptable representative has provided informed consent and the patient has assented (where relevant) to participation in the trial 2. the patient is a child that weighs between 5.00 kg and 15.00 kg inclusive 3. the patient has falciparum malaria as evidenced by thick or thin blood smears of ≥ 500 p falciparum per mcl (patients with mixed infections may be included provided ≥ 500 p falciparum per mcl) 4. the patient has either: * severe or complicated falciparum malaria as determined by the investigator based on the who criteria for severity, and/or * uncomplicated falciparum malaria but is unable to tolerate oral medication as a result of gastrointestinal complications such as vomiting or diarrhoea. exclusion criteria: 1. the patient's legally acceptable representative does not provide informed consent for participation, or the child if capable, does not assent to participation in the trial. 2. ability to tolerate oral therapy 3. patient has received any antimalarial therapy within the 7 days prior to first study drug administration. 4. patient has evidence of significant co-infections (this does not include mixed plasmodium infections). 5. patient has a contraindication, allergy or is otherwise intolerant to either artemether or quinine .

Keywords: plasmodium infections remittent fever artemether artemesinins quinine malaria protozoan infections sublingual drug delivery parasitic disease antiprotozoan agents
dissonance eating disorder prevention: clinician led, peer led vs web delivered

Conditions: Eating Disorder Prevention

Summary: five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for eating disorder not otherwise specified (ed-nos), which includes subthreshold variants of these disorders. over half of those presenting for eating disorder treatment meet criteria for ed-nos and both threshold cases and ed-nos are marked by chronicity, relapse, distress, functional impairment, and increased risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse, morbidity, and mortality. anorexia and bulimia nervosa show stronger relations to suicide attempts, outpatient/inpatient treatment, and functional impairment than most other psychiatric disorders. treatment of eating disorders is very expensive, similar to the cost for schizophrenia treatment, and is effective for only 40-60% of patients. thus, a public health priority is to develop and disseminate effective eating disorder prevention programs.

although dozens of eating disorder prevention programs have been evaluated, only a dissonance-based program (the body project) has significantly reduced future onset of threshold and subthreshold eating disorders through long-term follow-up. an effectiveness trial found that the body project produced significant reductions in risk factors, eating disorder symptoms, and functional impairment relative to educational brochure controls, with some effects persisting through 3-yr follow-up when high school clinicians recruited students and delivered the program. these trials confirm the efficacy and effectiveness of the body project, but revealed a key dissemination barrier; it can be difficult to identify and recruit clinicians at high schools and colleges with the time and expertise to competently deliver the program. one solution to this key dissemination barrier is to train students in established peer leader programs at colleges to recruit high-risk students and deliver the program. another solution to this dissemination barrier would be to deliver the body project via the internet. because peer-led groups and internet delivery of the body project could markedly extend the reach and sustainability of this evidence-based program, we propose to conduct the first large multi-site effectiveness trial that directly compares the effects and cost effectiveness of peer-led body project groups, the ebody project intervention, and clinician-led body project groups to an educational video control condition.

Eligibility criteria:
inclusion criteria: * body image concerns * attend university of oregon, oregon state university, university of texas at austin, or southwestern university exclusion criteria: * meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder * suicidal ideation

Keywords: body image body dissatisfaction
ulipristal acetate in symptomatic uterine fibroid

Conditions: Uterine Fibroid; Heavy Menstrual Bleeding

Summary: this study evaluates the effectiveness and safety of ulipristal acetae (upa) in women with symptomatic uterine fibroids. those who fulfilled inclusion/exclusion criteria will be treated upa at daily dose of 5mg.

there is increasing evidence approving role of medical therapy in treatment of symptomatic uterine fibroid, in the context of women's desire to preserve fertility or not to undergo operation. among these hormonal therapies, ulipristal acetate (upa) is an orally administered selective progesterone receptor modulator commonly prescribed for treatment of uterine fibroid. this agent acts on causing apoptosis of the muscle cells inside the tumor and reducing the tumor matrix in case of uterine fibroid. upa at daily dose of 5 mg has been shown to decrease menstrual blood loss and reduce tumor size after 13 consecutive weeks of treatment.

Eligibility criteria:
inclusion criteria: * women aged 18-48 * regular cycle of 22-35 days interval and fsh \<=20 mui/ml. * \>=1 uterine fibroid of 3\<= d \< 10cm (regardless of location), diagnosed by transvaginal ultrasound. * heavy menstrual bleeding (blood loss \>80ml/cycle). * uterine size \< 16 weeks of ga on clinical examination. * agree to participate in the study. exclusion criteria: * previous or current treatment of uterus, cervix, ovarian or breast cancer. * previous endometrial ablation or uterine artery embolization. * abnormal pap's smear result within 12 months prior to recruitment. * endometrial hyperplasia within 6 months prior to recruitment. * uterine polyp \>2cm. * ovarian cysts 4cm diagnosed by transvaginal ultrasound. * severe anemia (hb 6 g/dl) or indication for blood transfusion. * coagulation disorder indicated for treatment. * increased liver enzyme level of twofold or more than normal upper limit. * previous use of sprm. * treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of gnrh analogue within 5 months prior to recruitment. * current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid

Keywords: ulipristal acetate
fasting mimicking diet (fmd) in conjunction with chemotherapy in advanced ovarian cancer

Conditions: Ovarian Cancer; Chemotherapeutic Toxicity

Summary: rates of grade 3-4 toxicity with carboplatin and paclitaxel chemotherapy range 26-84%. interventions to reduce toxicity are needed. short term fasting protects against toxic effects of chemotherapy without decreasing efficacy. in a prospective clinical trial of breast cancer patients randomized to fmd or regular diet during chemotherapy, less antiemetic was required in the fmd group; radiographic and pathologic responses were better in this group. this trial tests whether platinum-taxane chemotherapy combined with a fmd in advanced and recurrent ovarian, fallopian tube and primary peritoneal cancer patients is associated with decreased toxicity and/ or improved tumor response to therapy.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. all patients with advanced ovarian, fallopian tube and primary peritoneal carcinomas deemed appropriate candidates for neoadjuvant chemotherapy and patients with recurrent, platinum-sensitive disease (as defined by an interval of at least 6 months following completion of last platinum-based chemotherapy prior to disease relapse or progression) 3. ecog performance status of 0, 1 or 2. 4. adequate bone marrow reserve (absolute neutrophil count (anc) ≥1.5 x 109/l and platelet count ≥100 x 109/l). 5. adequate renal function defined as creatinine ≤1.5 x laboratory upper limit of normal (uln). 6. adequate hepatic function defined as: bilirubin ≤1.5 x uln alt and ast ≤3 x uln 7. bmi ≥19 kg/m2 exclusion criteria: 1. patients with malnutrition and/ or bmi \<19 2. patients with active eating disorders (as identified by history of pre-enrollment nutrition screen) 3. diabetes mellitus requiring medication management (both insulin and non-insulin requiring). patients with diabetes mellitus controlled by diet alone (i.e. patients not requiring anti-glycemic medications) are not excluded and are eligible for participation. 4. allergy to component of fasting mimicking diet (fmd) 5. patients with recurrent ovarian, fallopian tube and primary peritoneal carcinomas with relapse within 6 months of completion of last platinum-based chemotherapy regimen (i.e. patients with platinum-resistant disease)
acupuncture for cerebral vasospasm after subarachnoid hemorrhage

Conditions: SAH (Subarachnoid Hemorrhage); Cerebral Vasospasm

Summary: this study will evaluate acupuncture's effect of preventing vasospasm after sah. a total of 80 participants will be recruited and will be randomized to a study group or a control group. acupuncture, electroacupuncture and intradermal acupuncture will be done at every session in a study group, while mock transcutaneous electrical nerve stimulation(mock tens) and sham intradermal acupuncture will be carried out in a control group.

intervention starts within 96hours after sah, after ruptured aneurysms have been secured by endovascular coiling or surgical clipping. intervention is applied once a day, 6 days a week for 2 weeks(total 12 sessions) in addition to standard treatment such as prophylactic hhh therapy and nimodipine. sterile disposable, stainless steel acupuncture needles are used. primary outcome measurement is the occurrence of delayed ischemic neurological deficit between the study group and the control group. moreover, the incidence of angiographic vasospasm, tcd vasospasm, and vasospasm-related infarct on ct or mri, the change of nitric oxide(no) and endothelin-1 in plasma, mortality and participant's functional status using mrs will be compared.

Eligibility criteria:
inclusion criteria: * participants conforming to all the following conditions will be included: 1) sah verified by ct and cerebral angiography; 2) aneurysm treated by endovascular coiling or surgical clipping; 3) age \> 18 years; 4) hhs 1-4; 5) acupuncture treatment can start within 96 hours after sah; 6) participation is voluntarily and the informed consent signed. * healthy controls who matched with patients in gender and age exclusion criteria: * participants with any of the following conditions will be excluded: 1) traumatic or infectious sah; 2) hhs 5; 3) transcranial doppler (tcd) cannot performed; 4) heart, liver or renal failure; 5) presence of cardiac pacemaker.

Keywords: sah (subarachnoid hemorrhage) cerebral vasospasm acupuncture
comparing the diagnostic sensitivity and specificity of pleural fluid n-terminal pro b-type natriuretic peptide (nt-probnp) and other biochemical gradient criteria in distinguishing heart failure and non-heart failure related pleural effusions (centre study)

Conditions: Pleural Effusion; Heart Failure; Malignant Neoplasm; Fluid Overload; Hypoalbuminemia; Renal Failure; Cirrhosis; Infections

Summary: to assess the discriminative properties of pleural fluid (pf) n-terminal-prob-type-natriuretic-peptide (ntprobnp) levels in identifying heart failure (hf)-associated pleural effusions (pe).

objective: to assess the discriminative properties of pleural fluid (pf) n-terminal-prob-type-natriuretic-peptide (ntprobnp) levels in identifying heart failure (hf)-associated pleural effusions (pe). hypothesis to be tested: the pf ntprobnp levels are superior to existing methods including light's criteria, serum/pleural fluid (s/pf) protein gradient, and albumin gradient, in identifying transudates and distinguishing between hf- and non-hf-associated pe. design and subjects: a prospective case-control study involving patients with pe requiring thoracentesis, caused by hypervolaemia due to hf, diseases other than hf, and patients with pleural effusion without hypervolaemia. patient characteristics, pf results and effusion aetiology will be analysed. patient outcomes will be followed up to 3 months to confirm the aetiology of pe. clinical management of patients will not be affected. study instruments: pf of recruited patients will be analysed for albumin, protein, lactate dehydrogenase (ldh) levels and ntprobnp. the diagnosis of hf will be based on clinical features, serum ntprobnp and echocardiogram. main outcome measures: the performance of pf ntprobnp level in identifying hf-associated pe. data analysis: the pf ntprobnp level will be compared between effusions of different aetiologies. the optimal pleural fluid ntprobnp level with largest area under the receiver operating characteristic curve in identifying hf-associated pe will be determined. performance of pf ntprobnp level in identifying hf-associated pe, and other biochemical criteria in identifying transudates will be compared. echocardiographic findings will be correlated with the pf ntprobnp levels. expected results: the diagnostic performance of pf ntprobnp will be significantly better in identifying hf-associated effusion than other biochemical criteria.

Eligibility criteria:
inclusion criteria: * patients hospitalized for heart failure and pleural effusion * pleural tapping indicated for pleural fluid analysis. * aged 18 years old or above exclusion criteria: * history of intrapleural therapy (including talc and fibrinolytic) in the ipsilateral pleural space. * history of surgical decortication or pleurodesis in the ipsilateral pleural space. * ipsilateral thoracic or cardiac surgery in the past 3 months. * failure to obtain informed consent due to the patient's refusal or cognitive impairment.

Keywords: pleural fluid heart failure malignancy cancer echocardiography infection tuberculosis respiratory medicine
post market study using the xoft axxent system

Conditions: Breast Cancer

Summary: the purpose of this multi-center clinical study is to compile post market performance and safety data on the axxent system.

the purpose of this multi-center clinical study is to compile post market performance and safety data on the axxent system for the delivery of radiation therapy as part of breast conserving therapy in women with resected, early stage breast cancer.

Eligibility criteria:
inclusion criteria: * age \>50 years * tumor with tis, t1, n0, m0 - (ajc classification) * invasive ductal carcinoma or ductal carcinoma in situ * negative microscopic surgical margins of at least 1mm in all directions * adequate skin spacing between balloon surface and surface of the skin - (\> 7mm) exclusion criteria: * pregnancy or breast-feeding - (during the treatment portion of the study, sexually active women of childbearing age will be asked to use pregnancy prevention) * scleroderma, systemic sclerosis and active lupus * infiltrating lobular histology

Keywords: stage i stage ii breast cancer
sensory perception after thoracotomy

Conditions: Neuropathic Pain; Thoracotomy; Chronic Pain

Summary: the study will investigate characteristics of chronic pain after thoracotomy


Eligibility criteria:
inclusion criteria: * able to understand and give consent * can read * residing in denmark exclusion criteria: * unable to understand the written information in danish * abuse (medicine, drugs, alcohol) * severe psychiatric illness * conflicting neurological disease

Keywords: persistent pain neuropathic pain thoracotomy chronic pain
role of sub-conjunctival bevacizumab in post pterygium excision management

Conditions: Pterygium

Summary: a pterygium is a fibrovascular growth originating from the conjunctiva that grows onto the surface of the cornea. frequently, these pterygia will recur even after surgical resection. bevacizumab is an inhibitor of angiogenesis, which is needed for recurrent growth. the use of bevacizumab is poorly understood in inhibiting pterygium growth. the objective of this study is to compare the effects of wound healing and recurrence rates in postoperative bevacizumab versus pterygium excision alone.

this is a prospective trial. thirty-one patients with a primary pterygium of at least 2 mm in size and without any previous ocular surgery will be included. outcome measures will include best corrected visual acuity, intraocular pressure, recurrence, and any sight threatening complications at two weeks, two months, and six months postoperatively.

Eligibility criteria:
inclusion criteria: * any patient 18 years of age or older with a primary pterygium that extends at least 2 mm past the limbus exclusion criteria: * history of glaucoma * previous ocular surgery * steroid-response glaucoma * previous myocardial infarct * bleeding disorder * pregnancy * lack of patient cooperation

Keywords: pterygium bevacizumab recurrence of pterygium
the cardiovascular risk evaluation in men with prostate cancer study (care-pc) pilot feasibility study

Conditions: Prostate Cancer

Summary: the overarching goal of this trial is to develop mechanisms to improve cardiovascular care among such prostate cancer patients receiving adt by increasing patient awareness of individualized cardiovascular risk estimates and mitigation opportunities. patients will be given access to a web-based quality improvement tool to educate patients of cardiovascular risks in prostate cancer and to inform them of their individualized, estimated cardiovascular risk and guideline-based risk mitigation recommendations. the study will assess the feasibility of this web-based application as a cardiovascular education tool for patients with prostate cancer. the study will also evaluate if completion of the web-based tool improves cardiovascular care access and risk mitigation for patients with prostate cancer.


Eligibility criteria:
inclusion criteria: * men with prostate cancer \> 18 years of age who are currently receiving or will be receiving treatment with ≥ 6 months of adt * patients must be able to read and understand english. exclusion criteria: n/a
clinical trial of crocus kozanis administration in obese children and adolescents

Conditions: PreDiabetes; Obesity; Dyslipidemias

Summary: the study aims to investigate possible effects of per os crocus kozanis administration in children and adolescents with obesity


Eligibility criteria:
inclusion criteria: * age above 10 year-old * diagnosis of obesity according to international obesity task force criteria * presence of impaired glucose tolerance and/or impaired fasting glucose exclusion criteria: * overt diabetes (any type) * diagnosis of any chronic disease * previous use of dietary supplement with crocus or crocus sativus * administration of chronic medication
the effectiveness of self-management education and telephone follow-up in patient with copd exacerbation

Conditions: COPD (Chronic Obstructive Pulmonary Disease); Symptom Management; Self-care Agency

Summary: according to the 2024 gold guidelines, chronic obstructive pulmonary disease (copd) is defined as heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production, and/or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and/or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction. copd is one of the leading causes of mortality and morbidity in turkey and worldwide. since copd is an incurable and lifelong disease, it is important for patients to have high levels of self-management. the main questions it aims to answer are: 1. does self-management education and telephone follow-up intervention effect self-care agency and symptom management in people with copd exacerbation? 2. does self-management education effect self-care agency and symptom management in people with copd exacerbation? this study will evaluate the effect of self-management education and telephone follow-up on self-care agency and symptom management. patients hospitalized with copd exacerbation will be trained in the hospital and will be followed up by phone call after discharge. during the study, 3 groups were planned; group 1 will be educated and followed up by telephone group 2 will only receive education and no telephone follow-up. group 3 will not receive education and telephone follow-up, only standard care. it is planned to collect the data from the patients at the beginning of the study, at 1, 3 and 6 months. main outcomes: * level of self-care agency * level of symptom management the results obtained will be interpreted by comparing between 3 groups.


Eligibility criteria:
inclusion criteria: * diagnosed with copd for the last 1 year * diagnosis of global initiative for chronic obstructive lung disease (gold) stage iii or iv copd documented by pulmonary function testing * patients hospitalized for acute exacerbation of copd; * hospitalized for at least 3 days * having a personal mobile phone and the ability to use it, * being enough conscious and oriented to answer the questions, * voluntary patients exclusion criteria: * under 18 years old * withdrawal from the study at any phase * inability to be contacted by phone/mobile phone, * patient death

Keywords: copd (chronic obstructive pulmonary disease) symptom management telephone follow-up self-care agency